Good Laboratory Practice Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.

This 120 minute training course will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.

This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).

This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).

This webinar will discuss the terms GLP and GMP, their definition, similarities and differences and their application in the biologics or pharmaceuticals development environment.

This method validation training will address the regulatory requirements which apply at the various stages of product development, and suggest proven strategies for compliant and phase-appropriate analytical method validation.

This GLP training will guide you in developing your laboratory's incident management plan to ensure that your laboratory policies and procedures are in compliance and your patients, visitors and staff are protected from accidents or unexpected events.

This webinar will provide a detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation. You will learn steps towards laboratory accreditation and how to prepare for an ISO 17025 audit.

This 90-minute webinar will help you to develop a sound bioanalytical process to ensure quality data. It will cover techniques for bioanalytical data management for the purpose of assuring a regulatory agency that the data have been collected, managed, and archived to the highest standards of quality assurance. You will understand the aspects of bioanalysis that can be run according to GLPs and the aspects in which GLPs do not apply.

This webinar on archiving GLP records will discuss the options for managing large archiving facilities to small facilities with one-room archives. You will receive practical tips on how to correct mistakes that agencies have cited regarding archiving.

This Good Laboratory Practice training defines deviations and unexpected events, the similarities and differences between deviations and amendments, and will present strategies to minimize the occurrence of unnecessary deviations.

This GLP (Good Laboratory Practices) webinar presents a straightforward summarization of the roles and responsibilities of all the people that contribute to a GLP study.

This GLP (Good Laboratory Practices) webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. The GLP final study report represents the last chance for a study team to present their results in a clear and compelling manner. The report may also be a place where difficulties can be explained so that the study provides meaningful and trustworthy information. This webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. It provides two areas of concentration: (1) the best practices in final report writing and (2) the step-by-step process of closing studies.

This webinar will discuss how to perform pre-study GLP compliance audits and what to look for at candidate nonclinical CRO This webinar will be valuable for any member of a pharmaceutical or biotechnology organization charged with placing or monitoring nonclinical GLP safety studies.

This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.

An Annual GLP training is a requirement for all personnel involved in Good Laboratory Practices (GLP) studies. The webinar course serves both as an initial training for new employees, new to GLP concepts will serving as a refresher course for experienced senior employees. The webinar provides an overview of the GLP to remind the attendees of the regulatory requirements for organizations in which bioanalytical testing is conducted.